Remote Activity Monitored by Fitbit Charge 3 in Investigating Daily Step and Sleep Data in Participants With Head and Neck Cancer Undergoing Radiation Therapy

RAMP (Remote Activity Monitoring Pilot): A Feasibility Study Investigating Daily Step and Sleep Data in Combination With Electronic Patient-Reported Outcomes in Adult Patients With Head and Neck Cancer

This pilot trial studies remote activity monitored by Fitbit Charge 3 in investigating daily step and sleep data in participants with head and neck cancer who are undergoing radiation therapy. A wearable remote activity tracking device, such as the Fitbit Charge 3, may help to detect early signs of treatment or disease-related symptoms, improve quality of life, decrease emergency room visits, and decrease hospitalizations in participants with head and neck cancer.

Study Overview

• Status: Completed
• Conditions: Head and Neck Carcinoma
• Intervention / Treatment: Device: Monitoring Device

Detailed Description

PRIMARY OBJECTIVES:

I. Determine compliance with remote activity monitoring (RAM) in patients receiving radiotherapy (RT) or chemoradiotherapy (CRT) for head and neck cancer (HNC).

SECONDARY OBJECTIVES:

I. Evaluate feasibility of recruitment to the Remote Activity Monitoring Pilot (RAMP).

II. Investigate patient acceptability of RAM. III. Evaluate compliance with electronic patient-reported outcomes (ePROs) in this patient population.

IV. Estimate the change in average daily steps associated with a one-unit change in health score as collected on ePRO analysis (analyze associations between RAM data and ePROs).

V. Investigate correlations among step data, quality of life (QOL), and emergency room (ER) visits/hospitalizations.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Sidney Kimmel Cancer Center at Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subjects have head and neck cancer as defined in history and physical
• Patients are eligible to be treated with RT or CRT and plan to start treatment
• Patients are capable of giving informed consent
• Patients must be able to read and/or to speak English
• Patients who are 18 years of age or older
• Women of reproductive potential should have a negative serum or urine pregnancy test within the week prior to radiation CT planning scan

Exclusion Criteria:

• Patients who cannot read or speak English
• Patients who are not candidates for RT/CRT treatment.
• Women of childbearing potential who are pregnant or breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device Feasibility (Fitbit Charge 3); Participants wear the Fitbit Charge 3 device from the time of CT simulation for RT planning throughout the entire RT course.	Device: Monitoring Device; Wear Fitbit Charge 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of time patients wear the Fitbit Charge 3 device (compliance)	Daily compliance with remote activity monitoring (RAM) will be defined as wearing the device for 19/24 hours daily (80% daily use). Overall study period compliance will be defined as usage of the device for at least 70% of the days under observation where it should have been worn. The overall study period compliance rate along with a one-sided exact 95% confidence interval will be estimated.	Through study completion, an average of 3 months

Collaborators and Investigators

• Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Investigators: Principal Investigator: Voichita Bar-Ad, MD, Sidney Kimmel Cancer Center at Thomas Jefferson University

Publications and helpful links

Helpful Links

• Thomas Jefferson University Hospital
• Sidney Kimmel Cancer Center at Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2018
• Primary Completion (Actual): October 14, 2021
• Study Completion (Actual): October 20, 2021

Study Registration Dates

• First Submitted: March 21, 2018
• First Submitted That Met QC Criteria: April 3, 2018
• First Posted (Actual): April 5, 2018

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 20, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: 17D.653; JT 10656 (Other Identifier: JeffTrial Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No